D-0370-2024 Class II Terminated
FDA drug recall D-0370-2024 was initiated by B. Braun Medical Inc on Mar 6, 2024 and is designated Class II. Reason for recall: Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks. The recall status is terminated (terminated Apr 16, 2025). Affected quantity: 22,752 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 20, 2024
- Initiation Date
- Mar 6, 2024
- Termination Date
- Apr 16, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,752 bags
Product Description
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
Reason for Recall
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0370-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026